RUSCH

Primary DI
04026704009848
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN041785
Catalog number
120000-000110
Device description
Tracheostomy tube set, short, cuffed
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOHTube tracheostomy and tube cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955564000RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILERusch, Inc.1996-06-28JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704009842PackageGS12In Commercial Distribution
44026704009846PackageGS128Not in Commercial Distribution
04026704009848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670400984224026704009842
4402670400984644026704009846
04026704009848040267040098484026704009848

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, non-reinforced, non-customized, reusableA hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Lumen/Inner Diameter11Millimeter
Outer Diameter14.4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight; Keep dry

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709206905BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206912BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206936BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206950BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206967BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206974BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206981BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206998BivonaICU MEDICAL, INC.JOH2026-10-20
10887709207001BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206776BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206783BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206813BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206844BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206851BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206868BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206875BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206882BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206899BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206646BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206653BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206660BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206677BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206684BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206691BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206707BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206714BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206721BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206738BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206745BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206752BivonaICU MEDICAL, INC.JOH2026-10-16